BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES

    K Number: K072400 · Decision Mar 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    31
    Review Days
    213

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    Basic Information

    Device Name
    NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
    K Number
    K072400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sgmp Co., Ltd.
    Date Received
    August 27, 2007
    Decision Date
    March 27, 2008
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by Sgmp Co., Ltd.

    K Number Device Name
    K112693 NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
    K101822 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K101646 NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
    K072403 NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
    K072406 NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
    K071060 NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
    K052016 NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
    K042879 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
    K023537 NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
    K032294 NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING
    Search all 31 clearances from Sgmp Co., Ltd. →